A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed

INTERVENTION: Palmitoylethanolamide (PEA) can be sold as a dietary supplement for medical purposes under FSANZ (Food Standards Australia and NZ). Palmitoylethanolamide (PEA) as Levagen+ will be taken as a 700 mg dose in capsule form (4 x 175 mg capsules) at the onset of migraine symptoms according to the International Headache Society classification. During the enrolled period participants will be asked to complete their perceived migraine pain using a visual analogue scale (VAS). The VAS is to be completed online using the secure, personal electronic link provided at enrolment. At the requested time points the participant will be asked to score their pain by making a mark on the VAS at a point that they feel reflects the level of pain experienced at that point in time. If the participant is unable to complete the score electronically for any reason (e.g. light sensitivity, no internet available) they will also be provided with a printable copy of the VAS that can be completed and mailed back to trial investigators. If a score is made on paper for any time point, participants are instructed to post the original page with the score back to the trial investigators with a pre‐paid and addressed envelope supplied upon request. At the first sign of a migraine (this will be specific to the participants usual known symptoms), they will be asked to: ‐ Note the time and date of the migraine ‐ Score the pain being experienced Take a single dose (4 capsules) of the allocated product with water once symptoms occur. For the next 4 hours or until the pain subsides (whichever occurs first): ‐ Score the pain severity experienced in the diary provided every 30 minutes Rescue medication: Participants are able to consume conventional ‘rescue’ medication ( CONDITION: Migraines; ; Migraines Neurological ‐ Other neurological disorders PRIMARY OUTCOME: Change in migraine pain/severity as assessed by VAS for pain[Baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hour 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours (primary endpoint). ; ] SECONDARY OUTCOME: Change in migraine duration assessed by recording duration in migraine diary[Baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hour 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours with final recording being primary endpoint. ] Change in pain relief medication use as assessed by migraine diary[Baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hour 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours. ] INCLUSION CRITERIA: ‐ Adults aged over 18 ‐ No recent history (within 2 years) of clinically significant medical conditions including, but not limited to, malignancy (and treatment for malignancy), cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled*. ‐ Participant’s full agreement and ability to consent to participation in the study ‐ At least 1 migraine (not headache) episode every 2 months as classified according to the International Classification of Headache Disorders, 3rd edition (ICHD3) for migraines published by the International Headache Society as detailed in section “Classificationâ€� ‐ Access to a computer or smartphone for completing online questionnaires and events. * A medical condition will be considered uncontrolled if the participant reports ongoing treatment, a change of either medication type o